Closed-loop Control of Postprandial Glucose Levels After Meals With Different Macronutrients Content in Adults With Type 1 Diabetes

What Was Tested

The trial (phase 2) is built around Insulin (regular human).

Carbohydrates are the main determinant of post-meal glucose excursion.

Few studies have looked at the effect of macronutrients other than carbohydrates on postprandial glucose excursions with the closed-loop strategy.

It had four arms (groups): Carbohydrate meal (active comparator), Carbohydrate + fat meal (active comparator), Carbohydrate + protein meal (active comparator) and Carbohydrate + fat + protein meal (active comparator).

The registry classes the interventions as device, drug and other.

Who Took Part

The registry lists 15 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Males and females ≥ 18 years old. Clinical diagnosis of type 1 diabetes for at least one year. The subject will have been on insulin pump therapy for at least 3 months and currently using fast-acting insulin analog (Lispro, Aspart or Guilisine).

The full record lists 4 inclusion and 8 exclusion criteria; among the exclusions: recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery; ongoing pregnancy; severe hypoglycemic episode within 1 month of screening.

How the Study Was Run

It was run as a randomized, crossover and open-label study.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Each person switched between Insulin (regular human) and the comparison at some point, usually with a gap in between.

Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2016-06 with completion listed for 2017-09.

It ran at 1 site in Canada.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Area under the curve of sensor glucose levels.

It also tracked 10 secondary outcomes, for example Mean sensor glucose levels, Peak glucose excursion, Time to peak glucose, Total insulin delivery, Standard deviation of glucose levels and Coefficient of variation of glucose levels.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Insulin (regular human) in 15 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Insulin (regular human) compound page, all human trials.